Adaptive Radiotherapy for Patients With GBM (ART-GBM)
ART-GBM: Feasibility Study of Adaptive Radiotherapy (ART) for Patients With Glioblastoma (GBM)
This is a single institution single arm feasibility study of MRI-guided, personalized adaptive radiation therapy with reduced margins for patients with glioblastoma.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The goal of this study is to evaluate MRI-guided adaptive radiation therapy to personalize radiotherapy planning for patients with glioblastoma, reduce margins, minimize toxicity, and improve survival.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Marlowe Estioko
- Telefonnummer: 267-343-6483
- E-mail: Marlowe.estioko@pennmedicine.upenn.edu
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
-
Kontakt:
- Marlowe Estioko
- Telefonnummer: 267-343-6483
- E-mail: Marlowe.estioko@pennmedicine.upenn.edu
-
Ledende efterforsker:
- Emily Lebow, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically confirmed IDH-wildtype glioblastoma (WHO Grade 4)
- Age ≥ 18 years
- Karnofsky Performance Status ≥ 60
- Planned 30 or 15 fractions of radiation therapy with or without concurrent systemic therapy
- Ability to undergo MRI imaging with IV gadolinium contrast
- Ability to provide written informed consent
- Multifocal tumors permitted if clinician anticipates they will be encompassed in a single radiation plan
Exclusion Criteria:
- Prior intracranial radiotherapy
- Multicentric disease
- Leptomeningeal dissemination
- Pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: MRI-Guided Adaptive Radiation Therapy
The study intervention is MRI-guided adaptive radiation therapy with reduced treatment margins among patients with glioblastoma. |
The study intervention is MRI-guided adaptive radiation therapy with reduced treatment margins among patients with glioblastoma. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of MRI-Guided Adaptive Radiotherapy
Tidsramme: 44 months
|
Feasibility will be defined as the proportion of patients who complete at least 2 out of 3 planned biweekly offline MRI-guided adaptations during the 6 week course of radiation therapy without any delay in scheduled treatment delivery (or 1 of the 2 planned offline adaptation during a 3 week course). Feasibility will be considered acceptable if ≥ 70% of enrolled patients meet this criterion. |
44 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patterns of Failure after Adaptive Radiation Therapy
Tidsramme: 44 months
|
Patterns of failure will be analyzed relative to the target volumes and dose distributions and categorized as central (in field), marginal, or out of field. |
44 months
|
|
Overall Survival
Tidsramme: 44 months
|
Determine overall survival following adaptive radiation therapy and compare survival outcomes with a propensity score matched historical cohort treated with standard radiotherapy. |
44 months
|
|
Patient-Reported Symptom Burden, Functioning, and Quality of Life
Tidsramme: 44 months
|
Longitudinal changes in patient reported symptoms, functional interference, neurologic function, and quality of life as assessed by validated patient reported outcome measures. |
44 months
|
|
Rates of Clinician Reported Toxicity
Tidsramme: 44 months
|
Incidence and severity of treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
44 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Emily Lebow, MD, University of Pennsylvania
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UPCC 09326
- 26-7494 (Anden identifikator: University of Pennsylvania Institutional Review Board)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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